The following data is part of a premarket notification filed by Concord/portex with the FDA for New-vent.
| Device ID | K911809 |
| 510k Number | K911809 |
| Device Name: | NEW-VENT |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Contact | Robert Wheeler |
| Correspondent | Robert Wheeler CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-23 |
| Decision Date | 1991-08-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NEW-VENT 72149923 0754175 Dead/Expired |
DOVER CORPORATION 1962-07-27 |